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Last Updated: April 6, 2025

CLINICAL TRIALS PROFILE FOR CARISOPRODOL


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All Clinical Trials for carisoprodol

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT01421433 ↗ A Comparative Study Between Lysine Clonixinate+Cyclobenzaprine and Caffeine+Carisoprodol+Sodium Diclofenac+Paracetamol Unknown status Pharmagenix Projetos em Medicina Farmacêutica Ltda. Phase 3 2012-05-01 Non inferiority, multicentric, double blind study whose the primary objective is to compare the effectiveness of two products in pain reduction. Primary endpoint: reduction in pain average at day 7 compared to day 1(baseline), using Analogue Visual Scale (AVS) for pain evaluation. Secondary endpoint: to evaluate the products safety at the gastrointestinal system.
NCT00671502 ↗ A Study to Evaluate Two Formulations of Carisoprodol in Subjects With Musculoskeletal Spasm of the Lower Back Completed Meda Pharmaceuticals Phase 3 2008-04-01 The purpose of this study is to determine if two sustained released formulations of carisoprodol are more effective than placebo.
NCT00671879 ↗ Study to Evaluate Two Formulations of Carisoprodol in Subjects With Musculoskeletal Spasm of the Lower Back Completed Meda Pharmaceuticals Phase 3 2008-04-01 The purpose of this study is to determine if two sustained released formulations of carisoprodol are more effective than placebo.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 3 of 3 entries

Clinical Trial Conditions for carisoprodol

Condition Name

220-0.200.20.40.60.811.21.41.61.822.2Lower Back PainLow Back Pain[disabled in preview]
Condition Name for carisoprodol
Intervention Trials
Lower Back Pain 2
Low Back Pain 2
[disabled in preview] 0
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Condition MeSH

44000.511.522.533.54Low Back PainBack Pain[disabled in preview]
Condition MeSH for carisoprodol
Intervention Trials
Low Back Pain 4
Back Pain 4
[disabled in preview] 0
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Clinical Trial Locations for carisoprodol

Trials by Country

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Trials by Country for carisoprodol
Location Trials
United States 48
Brazil 1
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Trials by US State

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Trials by US State for carisoprodol
Location Trials
New Jersey 2
Michigan 2
Louisiana 2
Georgia 2
Florida 2
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Clinical Trial Progress for carisoprodol

Clinical Trial Phase

100.0%000.511.522.533.54Phase 3[disabled in preview]
Clinical Trial Phase for carisoprodol
Clinical Trial Phase Trials
Phase 3 4
[disabled in preview] 0
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Clinical Trial Status

50.0%25.0%25.0%0-0.200.20.40.60.811.21.41.61.822.2CompletedUnknown statusWithdrawn[disabled in preview]
Clinical Trial Status for carisoprodol
Clinical Trial Phase Trials
Completed 2
Unknown status 1
Withdrawn 1
[disabled in preview] 0
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Clinical Trial Sponsors for carisoprodol

Sponsor Name

trials000111112222Meda PharmaceuticalsPharmagenix Projetos em Medicina Farmacêutica Ltda.Farmoquimica S.A.[disabled in preview]
Sponsor Name for carisoprodol
Sponsor Trials
Meda Pharmaceuticals 2
Pharmagenix Projetos em Medicina Farmacêutica Ltda. 1
Farmoquimica S.A. 1
[disabled in preview] 0
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Sponsor Type

80.0%20.0%000.511.522.533.54IndustryOther[disabled in preview]
Sponsor Type for carisoprodol
Sponsor Trials
Industry 4
Other 1
[disabled in preview] 0
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Carisoprodol: Clinical Trials, Market Analysis, and Projections

Introduction to Carisoprodol

Carisoprodol, commonly known by the brand name Soma, is a centrally acting skeletal muscle relaxant used to treat acute, painful musculoskeletal conditions. Here, we will delve into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Efficacy

Overview of Clinical Trials

A significant clinical trial involving carisoprodol was a 7-day, multicenter, randomized, double-blind, placebo-controlled study. This trial aimed to determine the efficacy and safety of carisoprodol at a dosage of 250 mg three times daily and at bedtime for patients with acute, painful muscle spasm of the lower back[1].

Key Findings

  • Patient-Rated Outcomes: Carisoprodol was significantly more effective than placebo for patient-rated global impression of change and patient-rated relief from starting backache. The mean scores for these endpoints were 2.24 vs. 1.70 (p < 0.0001) and 1.83 vs. 1.12 (p < 0.0001), respectively[1].
  • Onset of Improvement: Patients treated with carisoprodol experienced moderate or marked improvement in 3 days, compared to 6 days for those receiving placebo (p < 0.0001)[1].
  • Safety and Tolerability: No patients discontinued treatment with carisoprodol due to drowsiness, and there were no serious adverse events or clinically significant effects on laboratory values or vital signs[1].

Mechanism of Action and Limitations

Carisoprodol works by impairing psychomotor performance and is indicated for the relief of discomfort related to acute, painful musculoskeletal conditions. However, it should only be used for acute treatment periods up to two or three weeks, as adequate evidence of effectiveness for more prolonged use has not been established. It is also not recommended in pediatric patients less than 16 years of age[4].

Market Analysis

Global Market Share and Demand Forecast

The global carisoprodol market is subject to various market dynamics and forecasts. Here are some key points:

  • Market Size and Growth: The global carisoprodol market is part of the broader specialty chemicals and manufacturing industry. Market research reports indicate a steady demand for carisoprodol, driven by its efficacy in treating musculoskeletal conditions[5].
  • Regional Markets: The market is segmented by region, with different regions showing varying levels of demand. The reports provide detailed forecasts up to 2030, highlighting growth trends and market share[2][5].

Pricing and Licensing

Market research reports on carisoprodol are available for purchase, providing comprehensive data and forecasts. These reports are priced starting at USD 2,900 for a single user license, offering valuable insights into global market data and trends[5].

Market Projections

Forecast Period 2024-2030

  • Growth Trends: The global carisoprodol market is expected to grow steadily over the forecast period. Market research reports indicate that the demand for carisoprodol will continue due to its established efficacy and the ongoing need for effective treatments for musculoskeletal conditions[2][5].
  • Market Share: The market share of carisoprodol is expected to remain significant within the skeletal muscle relaxant segment. The reports provide detailed forecasts and rankings, helping stakeholders understand the market dynamics and potential opportunities[2].

Challenges and Opportunities

Regulatory Environment

The regulatory environment plays a crucial role in the development and marketing of carisoprodol. FDA guidelines and approvals are essential for ensuring the safety and efficacy of the drug. Compliance with these regulations is a key factor in maintaining market presence[3].

Safety and Side Effects

While carisoprodol has been shown to be effective, it also has potential side effects, including impairment of psychomotor performance and the risk of dependence. These factors must be carefully managed to ensure patient safety and maintain market trust[4].

Industry Trends and Impact

Clinical Trials Market

The broader clinical trials market, which includes trials for carisoprodol, is expected to grow significantly. The U.S. clinical trials market, for example, is projected to grow from USD 27.07 billion in 2024 to USD 41.57 billion by 2033, with a CAGR of 4.88% during the forecast period. This growth is driven by the increasing need for innovative treatments and the importance of clinical trials in drug development[3].

Key Takeaways

  • Clinical Efficacy: Carisoprodol has been proven to be significantly more effective than placebo in treating acute, painful musculoskeletal conditions.
  • Market Growth: The global carisoprodol market is expected to grow steadily over the forecast period, driven by its established efficacy and ongoing demand.
  • Regulatory Compliance: Adherence to FDA guidelines and safety protocols is crucial for maintaining market presence and ensuring patient safety.
  • Industry Trends: The broader clinical trials market is expected to grow, driven by the need for innovative treatments and the critical role of clinical trials in drug development.

FAQs

What is the primary indication for carisoprodol?

Carisoprodol is indicated for the relief of discomfort related to acute, painful musculoskeletal conditions.

How effective is carisoprodol compared to placebo?

Carisoprodol was significantly more effective than placebo in patient-rated global impression of change and patient-rated relief from starting backache, with mean scores of 2.24 vs. 1.70 and 1.83 vs. 1.12, respectively[1].

What are the limitations of using carisoprodol?

Carisoprodol should only be used for acute treatment periods up to two or three weeks, and it is not recommended in pediatric patients less than 16 years of age[4].

What is the projected growth of the global carisoprodol market?

The global carisoprodol market is expected to grow steadily over the forecast period 2024-2030, driven by its established efficacy and ongoing demand[2][5].

Are there any safety concerns associated with carisoprodol?

Yes, carisoprodol can cause impairment of psychomotor performance and has the risk of dependence. It is also classified as Pregnancy Category C, and its use during breastfeeding should be approached with caution[4].

Sources

  1. Double-blind, placebo-controlled trial of carisoprodol 250-mg tablets... - PubMed.
  2. Carisoprodol - Global Market Share and Ranking, Overall Sales and Demand Forecast 2024-2030 - Market Research Reports® Inc.
  3. U.S. Clinical Trials Market Size Industry Analysis Report, 2033 - BioSpace.
  4. Carisoprodol: Uses, Interactions, Mechanism of Action - DrugBank.
  5. Global Carisoprodol Market Research Report 2024 - Market Research Reports® Inc.

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